A Registry for Patients Taking Uptravi

NCT ID: NCT03278002

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-01

Study Completion Date

2021-09-21

Brief Summary

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This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Group/Cohort Information

This is a US multi-center, prospective, real world, observational drug registry enrolling patients actively treated with Uptravi. Participating patients will be followed prospectively for a maximum of 18 months from the date of enrollment into the registry.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Signed patient informed consent form (ICF).
* Patients ≥ 18 years of age at time of Uptravi initiation, and
* Patients who initiate Uptravi:

* at enrollment, or
* less than or equal to 60 days prior to enrollment and have a documented titration regimen (defined as all documented dose changes including, but not limited to: starting dose and dates and highest tolerated dose and dates)

Exclusion Criteria

* Patients previously exposed to Uptravi treatment during a clinical trial.
* Patients that previously discontinued Uptravi for any reason, prior to study enrollment (discontinuation defined as an interruption of therapy greater than or equal to 30 days).
* Patients enrolled in a blinded clinical trial or in a clinical trial involving an unapproved drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Actelion

Role: STUDY_DIRECTOR

Actelion

Locations

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University of South Alabama

Mobile, Alabama, United States

Site Status

Pulmonary Associates

Phoenix, Arizona, United States

Site Status

Cardioivascular Consultants, Ltd.

Phoenix, Arizona, United States

Site Status

University of Arizona-Clinical Translational and Regenerative Medicine

Tucson, Arizona, United States

Site Status

University of California San Diego

La Jolla, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

VA Greater Los Angeles Healthcare Center

Los Angeles, California, United States

Site Status

UCSF Medical Center

San Francisco, California, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Lundquist Institute for Biomedical Innovation at Harbor-UCLA

Torrance, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Banner Health Research Institute

Greeley, Colorado, United States

Site Status

Florida Lung Asthma and Sleep Specialists

Celebration, Florida, United States

Site Status

Broward Pulmonary and Sleep

Fort Lauderdale, Florida, United States

Site Status

University of Florida, HSC

Gainesville, Florida, United States

Site Status

West Pasco Pulmonary Associates

Hudson, Florida, United States

Site Status

University of Florida-Jacksonville College of Medicine

Jacksonville, Florida, United States

Site Status

Central Florida Pulmonary Group

Orlando, Florida, United States

Site Status

University of South Florida

Tampa, Florida, United States

Site Status

Cleveland Clinic Florida

Weston, Florida, United States

Site Status

Emory University School of Medicine

Atlanta, Georgia, United States

Site Status

Wellstar Marietta Pulmonary Medicine

Marietta, Georgia, United States

Site Status

University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

Indiana University Health

Indianapolis, Indiana, United States

Site Status

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, United States

Site Status

CIC Associates

Clive, Iowa, United States

Site Status

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Norton Pulmonary Specialists

Louisville, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Oschner Clinic Foundation/Oschner Medical Center

New Orleans, Louisiana, United States

Site Status

Chest Medicine Associates

South Portland, Maine, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

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Tufts University Medical Center

Boston, Massachusetts, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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University of Michigan

Ann Arbor, Michigan, United States

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Sparrow Clinical Research Institute

Lansing, Michigan, United States

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William Beaumont Hospital

Troy, Michigan, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Research, Mercy Hospital Saint Louis

St Louis, Missouri, United States

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Somnos Clinical Research

Lincoln, Nebraska, United States

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University of Nebraska Medical Center

Omaha, Nebraska, United States

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Newark Beth Israel Medical Center

Newark, New Jersey, United States

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University of New Mexico

Albuquerque, New Mexico, United States

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Pulmonary Health Physicians, PC

Fayetteville, New York, United States

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Winthrop University Hospital

Mineola, New York, United States

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Northwell Health

New Hyde Park, New York, United States

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Mount Sinai Hospital

New York, New York, United States

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Columbia University Medical Center

New York, New York, United States

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Weil Cornell Medicine

New York, New York, United States

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Stony Brook University Medical Center

Stony Brook, New York, United States

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University of North Carolina Hospitals at Chapel Hill

Chapel Hill, North Carolina, United States

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Duke University Medical Center

Durham, North Carolina, United States

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The Lindner Research Center at The Christ Hospital

Cincinnati, Ohio, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Southwest General Health Center

Middleburg Heights, Ohio, United States

Site Status

Legacy Medical Group-Pulmonary and Sleep Clinic

Portland, Oregon, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Doylestown Health Cardiology

Doylestown, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Temple University Hospital

Philadelphia, Pennsylvania, United States

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Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

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University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

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York Hospital

York, Pennsylvania, United States

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Rhode Island Hospital

Providence, Rhode Island, United States

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AnMed Health Medical Center

Anderson, South Carolina, United States

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Baylor Scott and White Health

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

University of Texas, Houston Health Center

Houston, Texas, United States

Site Status

Methodist Healthcare of San Antonio

San Antonio, Texas, United States

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status

Inova Fairfax

Falls Church, Virginia, United States

Site Status

Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Site Status

Providence Health & Services d/b/a/ Providence Sacred Heart Medical Center & Children's Hospital Providence Medical Research Center

Spokane, Washington, United States

Site Status

Multicare Institute for Research & Innovation

Tacoma, Washington, United States

Site Status

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, United States

Site Status

Aurora Research Institute / Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

CardioPulmonary Research, PSC

Guaynabo, , Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Kim NH, Hemnes AR, Chakinala MM, Highland KB, Chin KM, McLaughlin V, Zhao C, Narayan V, Farber HW. Patient and disease characteristics of the first 500 patients with pulmonary arterial hypertension treated with selexipag in real-world settings from SPHERE. J Heart Lung Transplant. 2021 Apr;40(4):279-288. doi: 10.1016/j.healun.2021.01.006. Epub 2021 Jan 15.

Reference Type DERIVED
PMID: 33526303 (View on PubMed)

Other Identifiers

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AC-065A402

Identifier Type: -

Identifier Source: org_study_id

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